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FDA Input Sought on Drug Repurposing

[ Price : $8.95]

FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet ...

Guide on Developing Clostridioides Difficile Infection

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FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile ...

Postapproval Pregnancy Safety Studies Guidance Available

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FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs...

Guide on Submitting Continuous Glucose Monitoring Data

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FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during...

Boston Scientific Device Correction on Certain Pacemakers

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Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy p...

White House Reportedly Moves to Oust Commissioner Makary

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Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy

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FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cho...

Atara says FDA outlined potential path for Cell Therapy Resubmission

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Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path ...

New CDER Biologics Compliance Program Explained

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Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...

Report says Makary May Face Ouster Amid White House Tensions

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Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...